The “EU chemicals strategy for sustainability” questions regulatory toxicology as we know it: is it all rooted in sound scientific evidence?

Herzler, Matthias; Marx‐Stoelting, Philip; Pirow, Ralph; Riebeling, Christian; Luch, Andreas; Tralau, Tewes; Schwerdtle, Tanja; Hensel, Andreas

doi:10.1007/s00204-021-03091-3

Cited by 27 publications

(19 citation statements)

References 17 publications

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“…The current framework has been successful in allowing the use of chemicals for the benefit of society without causing harm (Herzler et al 2021 ) and there is a reluctance to change to a new process until it has been properly validated. We need to look back through the current animal-based methods that have been refined over the years of their use.…”

Section: Discussionmentioning

confidence: 99%

“…The outcome of a hazard assessment process should be judged on whether an adequate hazard profile results in terms of type and category of hazard and setting of safe dose limits, not on whether all the endpoints from individual conventional toxicology studies could be predicted. It has been argued that the acceptability of a new approach to chemical safety assessment should be judged on whether it provides results which allow appropriate risk management actions to protect human health (Daston et al 2015 ; Herzler et al 2021 ; Lanzoni et al 2019 ; Moné et al 2020 ; Tralau et al 2015 ).…”

Section: Introductionmentioning

confidence: 99%

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A framework for chemical safety assessment incorporating new approach methodologies within REACH

Ball¹,

Bars

Botham

et al. 2022

Arch Toxicol

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The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A framework for chemical safety assessment incorporating new approach methodologies within REACH

Ball¹,

Bars

Botham

et al. 2022

Arch Toxicol

View full text Add to dashboard Cite

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“…In their Guest Editorial “EU chemicals strategy for sustainability questions regulatory toxicology as we know it: is it all rooted in sound scientific evidence?” published in this journal, several members of the German competent authority for risk assessment, the Federal Institute for Risk Assessment (BfR), raise concerns about the scientific justification for the CSS (Herzler et al 2021 ). We, as representatives of the international scientific community 1 appreciate, that a competent authority, which stands for a science-based risk assessment of chemicals, may properly express concern about the need to “restore human health and environment to a good quality status”.…”

Section: Commentarymentioning

confidence: 99%

The EU chemicals strategy for sustainability: in support of the BfR position

et al. 2021

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The EU chemicals strategy for sustainability (CSS) asserts that both human health and the environment are presently threatened and that further regulation is necessary. In a recent Guest Editorial, members of the German competent authority for risk assessment, the BfR, raised concerns about the scientific justification for this strategy. The complexity and interdependence of the networks of regulation of chemical substances have ensured that public health and wellbeing in the EU have continuously improved. A continuous process of improvement in consumer protection is clearly desirable but any initiative directed towards this objective must be based on scientific knowledge. It must not confound risk with other factors in determining policy. This conclusion is fully supported in the present Commentary including the request to improve both, data collection and the time-consuming and bureaucratic procedures that delay the publication of regulations.

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“…The latter is a precondition for mixture effects to occur, as are sufficiently high doses. It is for this reason that incidences of known mixture toxicity are generally low and that single substance assessments are in most cases considered sufficiently conservative (Herzler et al 2021 ). Yet, the ever-increasing use of and exposure to chemicals have led to regained regulatory awareness of potential mixture effects (Tralau et al 2021 ).…”

Section: Introductionmentioning

confidence: 99%

An approach for mixture testing and prioritization based on common kinetic groups

et al. 2022

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In light of an ever-increasing exposure to chemicals, the topic of potential mixture toxicity has gained increased attention, particularly as the toxicological toolbox to address such questions has vastly improved. Routinely toxicological risk assessments will rely on the analysis of individual compounds with mixture effects being considered only in those specific cases where co-exposure is foreseeable, for example for pesticides or food contact materials. In the field of pesticides, active substances are summarized in so-called cumulative assessment groups (CAG) which are primarily based on their toxicodynamic properties, that is, respective target organs and mode of action (MoA). In this context, compounds causing toxicity by a similar MoA are assumed to follow a model of dose/concentration addition (DACA). However, the respective approach inherently falls short of addressing cases where there are dissimilar or independent MoAs resulting in wider toxicokinetic effects. Yet, the latter are often the underlying cause when effects deviate from the DACA model. In the present manuscript, we therefore suggest additionally to consider toxicokinetic effects (especially related to xenobiotic metabolism and transporter interaction) for the grouping of substances to predict mixture toxicity. In line with the concept of MoA-based CAGs, we propose common kinetics groups (CKGs) as an additional tool for grouping of chemicals and mixture prioritization. Fundamentals of the CKG concept are discussed, along with challenges for its implementation, and methodological approaches and examples are explored.

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The “EU chemicals strategy for sustainability” questions regulatory toxicology as we know it: is it all rooted in sound scientific evidence?

Cited by 27 publications

References 17 publications

A framework for chemical safety assessment incorporating new approach methodologies within REACH

A framework for chemical safety assessment incorporating new approach methodologies within REACH

The EU chemicals strategy for sustainability: in support of the BfR position

An approach for mixture testing and prioritization based on common kinetic groups

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